Hypersensitivity; anaphylactoid reactions. Discontinue treatment if erythema multiforme or flu-like symptom; SJS occur; at 1st appearance of skin rash, mucosal lesions or any other sign of hypersensitivity. Not to be used as substitute for aspirin for prophylaxis of CV thromboembolic disease. Avoid use in patients w/ advanced renal disease. Contraindicated in patients w/ CV or cerebrovascular diseases; MI or CHF (NYHA II-IV); history of stenosed or occluded CHD or paresis, paralysis due to CVA. Increased risk of serious CV thrombotic events, MI & stroke; serious GI inflammation, ulceration, bleeding, & perforation. May diminish utility of diagnostic signs (eg, fever) in detecting infections. Patient w/ risk factors for developing CHD eg, HTN, hyperlipidemia, diabetes, smoking, elderly; dehydration; CV disease, using concomitant glucocorticoids, antiplatelet drugs (eg, aspirin), or other NSAIDs, alcohol, w/ prior history of, or active, GI disease eg, ulceration, GI bleeding or inflammatory conditions; compromised cardiac function, pre-existing edema, or other conditions predisposing to, or worsened by, fluid retention including those taking diuretics or otherwise at risk of hypovolemia. Carefully monitor patients at greater risk for renal toxicity; for evidence of development of more severe hepatic reaction while on therapy. Closely monitor patients w/ pre-existing CHF or HTN. Monitor BP during initiation & throughout the course of therapy; anticoagulation/INR after treatment initiation or changing dose. Rehydrate patient before initiating therapy. Avoid concomitant use w/ non-aspirin NSAIDs. Concomitant use w/ oral anticoagulants including warfarin/coumarin-type & novel oral anticoagulants (eg, apixaban, dabigatran & rivaroxaban); drugs metabolized by CYP2D6. May affect ability to drive & use machines. Not recommended in severe hepatic impairment (Child-Pugh class C). Severe renal impairment. Not to be used during 3rd trimester of pregnancy. May be associated w/ increased risk of miscarriage. May cause fetal dysfunction during 2nd or 3rd trimester of pregnancy. Closely monitor amniotic fluid vol in pregnant women during treatment. Lactation. Ped <18 yr.
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